WHO Collaborating Centre for Regulatory Control of Pharmaceuticals

The National Pharmaceutical Regulatory Agency (NPRA) is an institution established by the Ministry of Health Malaysia in 1978. It is a regulatory agency charged with the responsibility of quality assurance and regulatory affairs of pharmaceuticals.

The gazetting of the Control of Drugs and Cosmetics Regulations 1984 marked the beginning of a systematic regulatory control of pharmaceuticals marketed in Malaysia. The basic objective of this legislation is to ensure safety, efficacy and quality of pharmaceutical products used by the public for health care.

Under the ASEAN Technical Co-operation among Developing Countries (ASEAN TCDC) Program, NPRA has been chosen and recognised by the ASEAN countries as the regional training centre for quality control of pharmaceuticals. NPRA has been the host for the training program in quality control and has successfully conducted such training since 1986. Apart from that, NPRA has received trainees from ASEAN and other countries countries including Bangladesh, Pakistan, India, Sri Lanka, Macao, Hong Kong and Mongolia. Additionally, NPRA officers have been sent to Sri Lanka, Mongolia and Vietnam as consultants.

In view of the technical expertise and training capabilities of NPRA, the organisation was given recognition as a "WHO Collaborating Centre in the Regulatory Control of Pharmaceuticals" on 10 May 1996.

TERMS OF REFERENCE

To provide training in all aspects of pharmaceutical quality assurance programme and regulatory matters, both in the region as well as globally;

To carry out product analysis for reference purposes or on behalf of countries lacking quality control laboratories;

To collaborate closely with WHO in drug regulatory matters especially in the field of Prequalification both in assessment and inspection;

To contribute to WHO work on the International Pharmacopeia and on activities related to the establishment of new International Chemical Reference Substances (ICRS); and

To collaborate with WHO in the monitoring of Phamacovigilance / Adverse Drug Reactions reports as well as dissemination of information pertaining to products with quality defects and/or safety concerns.